Healthy MenNCT01710280
Palmitic Acid in the Sn-2 Position of Triacylglycerols and Postprandial Lipemia
A study testing High-fat meal containing native palm olein and High-fat meal containing interesterified palm olein in people with Healthy Men and Raised Fasting Plasma Triacylglycerol Concentrations, run by King's College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether high-fat meals rich in palmitic acid in the sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting triacylglycerol concentrations. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men, Raised Fasting Plasma Triacylglycerol Concentrations
- What is being tested?
- High-fat meal containing native palm olein and High-fat meal containing interesterified palm olein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- Non-smokers
- Aged 40-70 years
- Fasting TAG concentrations ≥1.5 mmol/L.
Who cannot join
- Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke), impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
- Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
- History of substance abuse or alcoholism (previous weekly alcohol intake >60 units/men)
- Current self-reported weekly alcohol intake exceeding 28 units
- Allergy or intolerance to any component of test meals
- Unwilling to restrict consumption of any source of fish oil for the length of the study
Show all 11Show fewer
- Weight change of >3kg in preceding 2 months
- Body Mass Index <20 and >35 kg/m2
- Fasting blood cholesterol > 7.8 mmol/L
- Current cigarette smoker.
- Current use of lipid lowering medication
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes & Nutritional Sciences Division, King's College London.
London, SE1 9NH
About this study
The purpose of this study is to determine whether high-fat meals rich in palmitic acid in the sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting triacylglycerol concentrations.
- Being tested
- High-fat meal containing native palm olein, High-fat meal containing interesterified palm olein
- Keywords
- Lipemia, Vascular function, Blood pressure
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat meal containing native palm oleinDietary supplement
High-fat meal containing interesterified palm oleinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Native palm olein | Active comparator | 75 g native palm olein Receives: Dietary Supplement: High-fat meal containing native palm olein |
| Interesterified palm olein | Experimental | 75 g interesterified palm olein Receives: Dietary Supplement: High-fat meal containing interesterified palm olein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental AUC (change from baseline in overall response) for plasma triacylglycerol concentrations
Measured: 1-6 h post-meal
Secondary outcomes (3)
Incremental AUC for plasma non-esterified fatty acid concentrations
Measured: 1-6 h post-meal
Changes from baseline in digital volume pulse
Measured: 2,4,5,6 h post-meal
Changes from baseline in blood pressure
Measured: 2,4,5,6 h post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy MenStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Wendy Hall, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710280
- Sponsor's protocol ID
- IRIS
- Status last verified
- Sep 2019
- First submitted
- 17 Oct 2012
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanders TA, Filippou A, Berry SE, Baumgartner S, Mensink RP. Palmitic acid in the sn-2 position of triacylglycerols acutely influences postprandial lipid metabolism. Am J Clin Nutr. 2011 Dec;94(6):1433-41. doi: 10.3945/ajcn.111.017459. Epub 2011 Oct 26.
PubMed 22030225
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palmitic Acid in the Sn-2 Position of Triacylglycerols and Postprandial Lipemia
- ClinicalTrials.gov ID
- NCT01710280
- Acronym / sponsor ID
- IRIS
- Keywords
- Lipemia, Vascular function, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether high-fat meals rich in palmitic acid in the sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting triacylglycerol concentrations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Native palm olein | Active comparator | Dietary Supplement: High-fat meal containing native palm olein75 g native palm olein |
| Interesterified palm olein | Experimental | Dietary Supplement: High-fat meal containing interesterified palm olein75 g interesterified palm olein |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males
- Non-smokers
- Aged 40-70 years
- Fasting TAG concentrations ≥1.5 mmol/L.
Key exclusion criteria (11 listed)
- Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke), impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
- Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
- History of substance abuse or alcoholism (previous weekly alcohol intake >60 units/men)
- Current self-reported weekly alcohol intake exceeding 28 units
- Allergy or intolerance to any component of test meals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-fat meal containing native palm olein | Dietary supplement | Native palm olein |
| High-fat meal containing interesterified palm olein | Dietary supplement | Interesterified palm olein |
Primary outcome
Incremental AUC (change from baseline in overall response) for plasma triacylglycerol concentrations
Time frame: 1-6 h post-meal
3 secondary outcomes
Incremental AUC for plasma non-esterified fatty acid concentrations
Time frame: 1-6 h post-meal
Changes from baseline in digital volume pulse
Time frame: 2,4,5,6 h post-meal
Changes from baseline in blood pressure
Time frame: 2,4,5,6 h post-meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Background: PubMed 22030225Sanders TA, Filippou A, Berry SE, Baumgartner S, Mensink RP. Palmitic acid in the sn-2 position of triacylglycerols acutely influences postprandial lipid metabolism. Am J Clin Nutr. 2011 Dec;94(6):1433-41. doi: 10.3945/ajcn.111.017459. Epub 2011 Oct 26.
- Primary publicationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat meal containing native palm olein and High-fat meal containing interesterified palm olein in people with Healthy Men and Raised Fasting Plasma Triacylglycerol Concentrations, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental AUC (change from baseline in overall response) for plasma triacylglycerol concentrations (time frame: 1-6 h post-meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01710280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.